Evaluating the Efficacy of Resveratrol Containing Mouthwash as Adjunct Treatment Periodontitis:

NCT ID: NCT05874882

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-12

Study Completion Date

2023-12-31

Brief Summary

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To evaluate the effectiveness of resveratrol mouthwash as adjunct to NSP treatment of periodontitis

Detailed Description

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* Measuring and comparing the efficacy of RV mouth wash in comparison with CHX and placebo mouth wash in improving the clinical periodontal parameters;
* Measuring the salivary cytokines (IL-6) before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
* Measuring the salivary RANKL before and after 4weeks of the use of RV mouth wash as adjunct to NSP treatment in comparison with other mouthwash by using enzyme-linked immunosorbent assay.
* Correlate the salivary cytokines IL-6 and salivary RANKL with clinical periodontal parameter and with each other.
* Evaluate the intervention by using Visual analog scale (VAS)- score-based questionnaire will be filled out by each participant at the end of the trial.

Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

the study include three groups. one of them is the study group in which the patient will use resveratrol mouthwash as adjunct to scaling, the second group use chlorhexidine mouthwas as adjunct to scaling while the third group will use a placebo. all the participants and the examiner are blinded regarding the type of the mouthwash they will be using
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
the supervisor will place the mouthwash in dark bottle with number so neither the examiner nor the patient will know the type of the mouthwash

Study Groups

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control

patients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Group Type PLACEBO_COMPARATOR

placebo mouthwash as adjunct to scaling and root planing in periodontitis patients

Intervention Type OTHER

patients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

chlorohexidine mouthwash

patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Group Type ACTIVE_COMPARATOR

chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients

Intervention Type OTHER

patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

resveratrol mouthwash

patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Group Type EXPERIMENTAL

resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients

Intervention Type OTHER

patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Interventions

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resveratrol mouthwash as adjunct to scaling and root planing in periodontitis patients

patients with periodontitis will receive scaling and rootplaning and a resveratrol mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Intervention Type OTHER

chlorhexidine mouthwash as adjunct to scaling and root planing in periodontitis patients

patients with periodontitis will receive scaling and rootplaning and a chlorhexidine mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Intervention Type OTHER

placebo mouthwash as adjunct to scaling and root planing in periodontitis patients

patients with periodontitis will receive scaling and rootplaning and a placebo mouthwash twice daily for 4 weeks. saliva will be collected at the 1st visit and after one month then biochemical analysis for inflammatory biomarker will be done. periodontal parameters also will be evaluated at the 1st visit and after 1 month

Intervention Type OTHER

Other Intervention Names

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resveratrol mouthwash (oraxil) chlorhexidine mouthwash (corsodyl) placebo

Eligibility Criteria

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Inclusion Criteria

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1. Participants need to be systemically healthy with age \> 18 years old.
2. Not taking antibiotic and anti-inflammatory drugs in the last three months.
3. At least 20 teeth should be present
4. Should have unstable periodontitis (PPD ≥ 5 or BOP at 4mm pocket)

Exclusion Criteria

1. Patients wearing fixed prosthesis (crowns, bridges or orthodontic appliances)
2. Those with chronic disease, immunocompromised patients, pregnant, on contraceptives or lactating women.
3. Those currently using any mouthwash.
4. Those on antibiotic therapy and anti-inflammatory medications during the study and in the last 3 months before the study.
5. Those having a history of hypersensitivity to any product used in the present study.
6. Those who are smokers or alcoholics.
7. Those who refuse to participate in the trial.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role lead

Responsible Party

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Hadeel Mazin Akram

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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College of Dentistry

Baghdad, None Selected, Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Hadeel MA [hakram], master

Role: CONTACT

07703991957

Facility Contacts

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hadeel M akram

Role: primary

07703991957

Other Identifiers

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744622

Identifier Type: -

Identifier Source: org_study_id

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